The following data is part of a premarket notification filed by Vestil Manufacturing Corp. with the FDA for Karma 800 Series Manual Wheelchair.
| Device ID | K021866 |
| 510k Number | K021866 |
| Device Name: | KARMA 800 SERIES MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | VESTIL MANUFACTURING CORP. 900 GROWTH PKWY. Angola, IN 46703 |
| Contact | Rick Michael |
| Correspondent | Rick Michael VESTIL MANUFACTURING CORP. 900 GROWTH PKWY. Angola, IN 46703 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-06 |
| Decision Date | 2002-06-14 |
| Summary: | summary |